CASE STUDY

Gates Biomanufacturing Facility

ORGANIZATION:

Cellular Therapy / Regenerative Medicine

INDUSTRY:

The Gates Biomanufacturing Facility fi nds the perfect fi t for their Quality Program in ECL2 & Q-Pulse

Background:

The Gates Biomanufacturing Facility part of the University of Colorado, is a brand-new facility

which opened up in April of 2015. The GBF is a campus-wide partnership comprised of the

Gates Center, Anschutz Medical Campus, CU School of Medicine (SOM), University of Colorado

Health, Children’s Hospital Colorado and the Gates Frontiers Fund. It serves UC Denver and the

surrounding area focusing on regenerative medicine and protein Biologics.

Regulated By: FDA

The Challenge:

The staff at the Gates Biomanufacturing Facility knew that the process of implementing

a system to support their quality program would be an intensive undertaking. It would be

important to not only fi nd a highly confi gurable system, but to fi nd a company with the specifi c

expertise in cellular therapy that also were experts in the system selected.

Why ECL2 and Q-Pulse?

Gabriel Orosco the Director of Quality for the Gates Biomanufacturing Facility identifi ed Q-Pulse

as a potential solution, but wanted to work with a U.S. based company for the implementation

and on-going support. ECL2 was the perfect fi t. Having an implementation specialist from ECL2

that had been responsible for quality systems at two different cellular therapy labs gave the

Gates Biomanufacturing Facility a unique advantage in the implementation process.

“The staff at ECL2 go out of their way to make things easy. They are active participants in the

consultation, providing multiple solutions for critical scenarios. It’s through this that you can

tell that they have been in your shoes, doing what you need to be doing.” According to Gabe.

Gabe continued on to say, “ECL2’s depth of knowledge in the regenerative medicine space

as well as the elegance and power associated with the Q-Pulse application, and were the

deciding factors in making our purchase. Together this combination has been the backbone of

our electronic quality management solution and it has set us apart in multiple vendor audits.”

Q-Pulse, ECL2 Quality Support Program (QSP)

SOLUTION:

The Solution:

ECL2 makes the implementation process a very interactive one to ensure every client gets a

system that fi ts their unique requirements. The process encourages a level of involvement that

creates excitement when the participants begin to see what can be accomplished.

“As a greenfi eld facility the Q-Pulse solution in concert with ECL2’s guidance made the potential

crippling situation of having infi nite choices into a focused activity to realize the platform’s true

potential.”

Looking at where they were and where they are now, Gabe had the following to say: “Things

have improved in that we have an amazing container for our quality management system

to be operated within. The hierarchy and implementation tools are well thought out. The

intelligence of the program will keep an institution from making bad implementation decisions

while providing a level of fl exibility you do not see with packages running 10 times the cost of

Q-Pulse.”

“Our ECL2 team was professional and friendly. It was painless. ECL2 is a true resource. I know

I can call and ask them a question that they own as a problem they need to solve.” Gabe

concluded by saying, “ECL2 is the defi nition of a hand in glove service.”

For more information on Q-Pulse please visit our website at

www.ECL2.com or contact us directly at 469.828.5006

or by email at inquiries@ECL2.com.

www.ECL2.com

inquiries@ECL2.com

Phone: (469) 828-5006

Fax: (972) 355-0594

The staff at ECL2 go out of

their way to make things easy.

They are active participants

in the consultation, providing

multiple solutions for critical

scenarios. It’s through this

that you can tell that they have

been in your shoes, doing

what you need to be doing.

The intelligence of the

program will keep an

institution from making bad

implementation decisions

while providing a level of

fl exibility you do not see with

packages running 10 times the

cost of Q-Pulse.

Gabriel Orosco,Director of Quality

the Gates Biomanufacturing

Facility